Device recall
Z-0500-2023: STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
FDA device recall · Class II · Stradis Medical, LLC dba Stradis Healthcare
Key facts
| Recall number (Z-number) | Z-0500-2023 |
|---|---|
| Recall event | 91124 |
| Product | STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular |
| Product code | OFL |
| Recalling firm | Stradis Medical, LLC dba Stradis Healthcare |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000111025 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database